Australian Politician Takes Issue with Transvaginal Mesh Implants

An Australian politician had harsh words for the pharmaceutical industry regarding transvaginal mesh implants used for pelvic organ prolapse and stress urinary incontinence. Senate Derryn Hinch, speaking in Parliament on Nov. 22, said pelvic mesh has “crippled thousands of mothers both here and overseas,” He went on to say that it was “one of the greatest medical scandals and abuses of mothers in Australian history.” Thousands of personal injury lawsuits have been filed over transvaginal mesh implants against various manufacturers. Women allege that the mesh devices were not properly tested, and caused injuries such as mesh erosion and organ damage.

According to the UK’s Ely Standard, Hinch met with two Australian mothers who said they were severely injured due to their pelvic mesh implants. They asked him to speak on behalf of all transvaginal mesh patients and call for an investigation. “This ‘harmless’ plastic netting can become brittle and start to break away in shards and splinters they start to float around the body causing inflammation and excruciating pain,” said Senate Hinch, “No wonder these slings have been called a torture device.”

Hinch even compared mesh safety issues to thalidomide, a morning sickness drug that caused deformed limbs in babies during the 1950s and 1960s.

Pelvic mesh advocates are applauding the outcry, Ely Standard reports. “Earlier this year Scottish Parliament said mesh implants are as bad a cover-up as asbestos and now this. The dangers are finally being [recognised],” said a mesh campaigner and journalist.

Hinch said the vaginal mesh should be inert, meaning it should not change once it contacts the body of tissue fluid, lead to allergic reactions, or cause other adverse events. “Tragically, painfully, dangerously, transvaginal mesh does not pass any of those tests. To make the nightmare worse these mesh hammocks are anchored deep into thigh and buttocks and pelvic region muscles where nerves grow through the mesh making it about impossible to remove things when the things go wrong,” he stated.

He said that women are never warned of the risks, which include erosion, nerve and organ damage and allergic reactions. Mesh implants may also lead to side effects such as bleeding, painful sex, vaginal scarring, return of prolapse, sepsis, immune system rejection, urinary problems and chronic pain. “It’s a national disgrace,” said Hinch.

Transvaginal Mesh Lawsuits, Settlements and Verdicts

Parker Waichman notes that many device makers are facing personal injury lawsuits involving transvaginal mesh. Several pelvic mesh multidistrict litigations (MDL) have been consolidated before U.S. District Judge Joseph Goodwin in West Virginia. The U.S. Judicial Panel on Multidistrict Litigation (JPML) establishes an MDL when there are many lawsuits with similar allegations. In this case, plaintiffs similarly allege that mesh implants were defectively designed, never properly tested and caused injuries. Device makers are accused of failing to disclose the risks. MDLs speed up the legal process for complex cases.

J&J’s Ethicon unit faces the largest number of transvaginal mesh lawsuits. Plaintiffs allege injuries from devices such as the Gynecare TVT and Prolift. For this first time this January, Ethicon offered to settle a large number of pelvic mesh cases. J&J agreed to settle 2,000 to 3,000 transvaginal mesh lawsuits for $120 million. Another 42,000 lawsuits are pending.

Some J&J transvaginal mesh lawsuits have gone to trial, leading to several verdicts. In September 2014, jurors awarded $3.27 million to the plaintiff. Verdicts of $11 million and $1.2 million were handed down in 2013 and 2014, respectively.

Lawsuits have also been filed over mesh devices manufactured by C.R. Bard. The first Bard pelvic mesh case to go to trial resulted in a $2 million verdict against the manufacturer.

C.R. Bard has also been involved in substantial transvaginal mesh litigation. Jurors found for the plaintiff when the first Bard mesh lawsuit went to trial, issuing a $2 million verdict against the device maker. A California jury awarded a $5.5 million verdict to a transvaginal mesh plaintiff.

In December 2014, Judge Goodwin urged Bard to settle its transvaginal mesh lawsuits. He referred to several large mesh verdicts that were issued, stating “I can’t imagine a corporation facing potentially billions of dollars in verdicts wouldn’t find it advisable to try to achieve a settlement for a much lesser sum,” Judge Goodwin said, according to a transcript of a Dec. 9, 2014 hearing. “I base that billions of dollars business on some of the rather large verdicts that we’ve had.” Bard agreed to settle 3,000 mesh cases in 2015 for $200 million.

American Medical Systems (AMS), a unit of Endo Pharmaceuticals, has also been sued over transvaginal mesh. The company agreed to settle an undisclosed number of vaginal mesh lawsuits in June 2013. In May 2014, the company announced another settlement, resolving 20,000 lawsuits for $830 million.

Boston Scientific was hit with several mesh verdicts, including two in November 2014 totaling over $45 million. A jury awarded a massive verdict of $73 million in September 2014. Additionally, a $14.3 million verdict issued in 2014 was recently upheld by Judge Goodwin.

Coloplast agreed to pay $16 million to settle roughly 4,000 transvaginal mesh injury lawsuits in 2015. Each plaintiff would receive roughly $40,000 under the settlement.

Transvaginal Mesh FDA Warnings

The U.S. Food and Drug Administration (FDA) issued warnings about transvaginal mesh implants in 2008 and 2011. In 2008, the agency said the most common injuries reported with transvaginal mesh include:

Some women also reported perforation of the bowels, bladder and blood vessels when the device was implanted.
In 2011, the agency amended its previous notification to state that complications associated with transvaginal mesh were “not rare”. The 2011 alert said transvaginal mesh does not appear to have clear benefits for POP patients compared to non-mesh methods and may present additional risks.

A number of mesh plaintiffs point out that the devices were cleared through 510(k), a route that allows devices onto the market without clinical data for safety or efficacy. Devices that are approved through 510(k) only need to prove that they are “substantially equivalent” to a previously approved product, even if that product was voluntarily recalled or was never assessed for safety itself. The FDA addressed these concerns by reclassifying transvaginal mesh from “moderate-risk” to “high-risk”. This means that mesh makers must go through the agency’s stricter premarketing approval, which requires companies to submit data proving their devices are safe and effective.

Filing a Transvaginal Mesh Lawsuit

If you or someone you know suffered injuries related to the use of transvaginal mesh implants, you may have valuable legal rights. Our transvaginal mesh lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).